Sequential Compression Device and Range of Motion Exercises on Distributive Peripheral Edema and Hemodynamic Stability Among Patients in Critical Care Units

NCT07305870 | Enrolling By Invitation DMC

• 1 other identifier: uok.coN.25.099
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives of The Study:

1. 1.Assess the effectiveness of sequential compression device on distributive peripheral edema and hemodynamic stability for patients in critical care units.
2. 2.Assess the effectiveness of range of motion on distributive peripheral edema and hemodynamic stability for patients in critical care units.
3. 3.Evaluate the synergic effectiveness of sequential compression device and range of motion on distributive peripheral edema and hemodynamic stability for patients in critical care units
4. 4.Find out the differences between the effectiveness of sequential compression device, range of motion, and synergic effectiveness of both interventions on distributive peripheral edema and hemodynamic stability
5. 5.Find out relationships between the effectiveness of sequential compression device, range of motion, and synergic effectiveness of both interventions with patients' demographic characteristics.

Conditions

Peripheral Edema

Outcome Measures

Primary Outcomes (2)

• Peripheral edema

  Firstly, the edema of lower extremities was measured for all patients in critical care units through pitting edema scale before selecting the participants, then the patients selected for the current study had pitting edema scale \>+1. Also, leg circumference had measured by using tape measurement.

  The degree of edema will be measured before applying interventions and after 5 consecutive days if study

• Hemodynamic Stability

  Hemodynamic parameters were also assessed before interventions. The Hemodynamic parameters that include the heart rate, blood pressure, respiratory rate, urine output and saturation of oxygen was measured by observation of the reading on the monitoring device that was used in critical care units and attached to the patient, the reading was documented by the researcher.

  Hemodynamic parameters will be measured before applying interventions and after 5 consecutive days if study

Study Arms (2)

Sequential Compression Device group

ACTIVE COMPARATOR

Sequential Compression Device (SCD) participants group involves a pump linked to calf and thigh braces with individual tubes, applying moderate pressure of approximately 60mmHg through a graduated air chamber in a sequential cycle across four compartments. The inflation lasts for 12 seconds followed by a 48-second deflation, with sessions lasting 2 hours daily for 5 consecutive days.

Device: Sequential compression device

Range of Motion exercises

ACTIVE COMPARATOR

The Range of Motion (ROM) Exercises program entails 20 minutes of flexion-extension movements for both limbs, conducted in two sessions per day over 5 days. Patients perform passive range of motion exercises for upper extremities including movements of fingers, wrists, elbows, and shoulders, as well as for lower extremities encompassing toe, ankle, knee, and hip movements. In addition control group will receive slandered care which is limps elevation

Device: legs exercises

Interventions

legs exercises DEVICE

The Range of Motion (ROM) Exercises program entails 20 minutes of flexion-extension movements for both limbs, conducted in two sessions per day over 5 days. Patients perform passive range of motion exercises for upper extremities including movements of fingers, wrists, elbows, and shoulders, as well as for lower extremities encompassing toe, ankle, knee, and hip movements. In addition control group will receive slandered care which is limps elevation

Range of Motion exercises

Sequential compression device DEVICE

Sequential Compression Device (SCD) protocol involves a pump linked to calf and thigh braces with individual tubes, applying moderate pressure of approximately 60mmHg through a graduated air chamber in a sequential cycle across four compartments. The inflation lasts for 12 seconds followed by a 48-second deflation, with sessions lasting 2 hours daily for 5 consecutive days.

Sequential Compression Device group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients who were hospitalized in critical care units.
• Subjects over the age of 18 years.
• Presence of peripheral edema (pitting edema ≥1+ in lower extremities).
• Patients how are hemodynamically stable.
• Patients how are able to tolerate positioning for interventions.

You may not qualify if:

• Patients with lymphedema.
• Patients with chronic kidney disease.
• patients with presence of deep vein thrombosis, severe peripheral arterial disease, or phlebitis.
• patients with open wounds, ulcers, or skin infections on lower limbs.
• patients with fractures, orthopedic surgery, or joint immobility in lower extremities.
• patients with severe cardiac failure or pulmonary edema.

Sponsors & Collaborators

• Karbala University: lead

Study Sites (1)

Kerbala health department

Karbala, Center, 56001, Iraq

Location

Study Officials

• Hussein H Jawad MGS study principal investigator

  Kerbala health department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: non
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Masters graduate student

Model Details: Sequential Compression Device (SCD) protocol involves a pump linked to calf and thigh braces with individual tubes, applying moderate pressure of approximately 60mmHg through a graduated air chamber in a sequential cycle across four compartments. The inflation lasts for 12 seconds followed by a 48-second deflation, with sessions lasting 2 hours daily for 5 consecutive days. The Range of Motion (ROM) Exercises program entails 20 minutes of flexion-extension movements for both limbs, conducted in two sessions per day over 5 days. Patients perform passive range of motion exercises for upper extremities including movements of fingers, wrists, elbows, and shoulders, as well as for lower extremities encompassing toe, ankle, knee, and hip movements. In addition control group will receive slandered care which is limps elevation

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 26, 2025
• Study Start: December 28, 2025
• Primary Completion: March 15, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)